Pharmaceutical companies must comply with many laws, standards, and rules of different source and type.
Skytechnology supports Customers to use computerized systems in a compliant way, thanks to the expertise in product/process compliance and in product development.
Skytechnology offers a whole set of services:
- Validation of computerized systems including
- Acquisition of Customer’s SOPs from the QA Officer regarding computer validation, change control, security and eventually the Validation Master Plan
- Acquisition of department and system relevant SOPs from System Owner
- Preparation of Validation Plan
- Definition of a Risk Assessment
- Identify of user requirements to define the intended use
- Life cycle control in case of developed systems and performance of Design Qualification
- Preparation of SOPs relevant to use, management, security and change control relevant to the system under validation
- Training to users about SOPs
- Definition of Qualification Protocols with relevant traceability matrices
- Test execution and issue of the relevant Qualification Reports
- Management of non-conformances in accordance to Customer’s SOP.
- Periodic review of validated computerized sytems to ensure that computerized systems are still validated in accordance with Customer’s SOP or a with ad hoc SOP written by Skytechnology
- Quality management services:
- Quality system maintenance with preparation and update of SOPs and instructions
- Support to incoming audits and audits to supplier
- Support to the management of CAPA
- Management of complaints according to 21 CFR requirements
- Training made according to customer needs. Training subjects include: 21 CFR Part 11, Annex 11, Computer Validation.